Streetbeat News

Regulatory

REGN

Regeneron Pharmaceuticals has announced that the FDA has accepted for priority review the Biologics License Application for Odronextamab, a treatment for lymphoma.

Portfolio Pulse from Benzinga Newsdesk

September 29, 2023 | 12:32 pm

NVO

Novo Nordisk A/s (NYSE:NVO) plans to introduce its weight-loss drug Wegovy in India by 2026, subject to regulatory approvals and supply adequacy. The move is strategic, given the high obesity rates in India. However, the company warns against purchasing counterfeit versions of Wegovy, which are already available online. Despite concerns over market maturity and pricing, Novo Nordisk remains confident about the drug's potential in India.

Portfolio Pulse from Vandana Singh

September 29, 2023 | 12:31 pm

SPY

The PCE Price Index for August has met the estimated value of 3.5% YoY. This is a key indicator of inflation and can influence the Federal Reserve's decisions on interest rates.

Portfolio Pulse from Benzinga Newsdesk

September 29, 2023 | 12:31 pm

SPY

The USA Core PCE Price Index for August was reported at 3.9%, in line with estimates but lower than the previous month's 4.3%.

Portfolio Pulse from Benzinga Newsdesk

September 29, 2023 | 12:31 pm

SPY

The USA Goods Trade Balance for August was reported at -$84.27 billion, better than the estimated -$91.20 billion and the prior figure of -$90.92 billion.

Portfolio Pulse from Benzinga Newsdesk

September 29, 2023 | 12:30 pm

AAPL

Apple Inc is in talks with Chinese officials to address concerns related to new regulations that will impose restrictions on the availability of foreign apps in the company's app store in China. The new rules could lead to the removal of tens of thousands of apps from Apple's app store in China. Apple's App Store was not included in the list of compliant app stores recently released by China's cyberspace regulator.

Portfolio Pulse from Vandana Singh

September 29, 2023 | 12:28 pm

LLY

Eli Lilly has settled a lawsuit filed by a former employee, Amrit Mula, who alleged wrongful termination after raising concerns about manufacturing practices and data falsification related to the diabetes drug Trulicity. The New Jersey facility in question has faced scrutiny from the FDA since 2019, when inspectors discovered the deletion of quality control data and inadequate audits. The U.S. Department of Justice initiated a criminal investigation in 2021 following a Reuters report detailing some of Mula's allegations. No charges have been filed yet.

Portfolio Pulse from Vandana Singh

September 29, 2023 | 12:15 pm

GERN

Geron Corporation has announced that the European Medicines Agency has validated its marketing authorization application for Imetelstat, a treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes. The review process is expected to last approximately 14 months.

Portfolio Pulse from Benzinga Newsdesk

September 29, 2023 | 12:11 pm

CCO

Clear Channel Outdoor Holdings, Inc. (NYSE:CCO) has settled a probe with the U.S. Securities and Exchange Commission (SEC) over bribery charges related to its former Chinese subsidiary, Clear Media Limited. The company will pay the SEC approximately $26.1 million in disgorgement, civil penalties, and pre-judgment interest. The U.S. Department of Justice has declined to pursue any charges against the company. Clear Channel's shares closed higher by 6.54% at $1.63 on Thursday.

Portfolio Pulse from Nabaparna Bhattacharya

September 29, 2023 | 12:11 pm

OTLK

Outlook Therapeutics has requested a Type A meeting with the FDA. The purpose of the meeting is not specified in the article.

Portfolio Pulse from Benzinga Newsdesk

September 29, 2023 | 12:06 pm